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A breakthrough, possibly a beginning

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Tuberculosis (TB) is a highly contagious infection caused by germs spread through the air from person to person. It usually affects the lungs, but can affect other parts of the body, including the brain, kidneys and spine. A person with TB can die without treatment. Tougher still is Multidrug-resistant tuberculosis (MDR-TB), a more difficult to treat form of TB.

MDR-TB is on the rise in many areas worldwide. It currently affects approximately 630,000 people around the world, and the World Health Organization has estimated that more than 2 million people will develop MDR-TB between 2011 and 2015. MDR-TB is characterized by resistance to two of the most powerful medicines in today’s standard four-drug TB treatment regimen. People infected with the disease have no option but to take a more complicated regimen of second-line drugs.

Understanding this critical health need, Janssen researchers discovered and developed the first TB therapy in 40 years with a new mechanism of action. In December 2012, SIRTURO™ (bedaquiline) Tablets was granted accelerated approval by the U.S. Food and Drug Administration for the treatment of pulmonary MDR-TB as part of combination therapy in adults. It is an important step in the development of new compounds for this serious and contagious disease.

“It’s really rare to be in a situation where you can say that you have contributed to the health of people like these MDR-TB patients,” says Koen Andries, Distinguished Research Fellow, Janssen. “It’s absolutely what Our Credo is all about.”

The U.S. approval marks a key step toward introducing SIRTURO™ in those regions of the world where MDR-TB has the greatest impact. SIRTURO™ is currently under review by three regulatory bodies including the European Medicines Agency (EU), State Food and Drug Administration (China) and Medicines Control Council (South Africa).

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